Cleared Traditional

MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159

K001698 · Cogent Light Technologies, Inc. · Gastroenterology & Urology
Jul 2000
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K001698 is an FDA 510(k) clearance for the MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159, a Image, Illumination, Fiberoptic, For Endoscope (Class II — Special Controls, product code FFS), submitted by Cogent Light Technologies, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on July 17, 2000, 45 days after receiving the submission on June 2, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K001698 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2000
Decision Date July 17, 2000
Days to Decision 45 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FFS — Image, Illumination, Fiberoptic, For Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

Similar Devices — FFS Image, Illumination, Fiberoptic, For Endoscope

All 25
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
K072521 · Cook Urological, Inc. · Nov 2007
PS SERIES
K061622 · Photonic Optische Gerate Gesmbh & Cokg · Mar 2007
TRU-CABLE
K063309 · Truphatek International, Ltd. · Jan 2007
ACCUTECH ENDOLITE PROBE
K061025 · Accutech Medical Technologies, Inc. · May 2006
SOVIS OPTIQUE'S ENDOSCOPIC CABLE
K023633 · Sovis Optique · Dec 2002
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · Smith & Nephew, Inc. · Jan 2000